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Completed

NCT Number: NCT03352388

Effects of Dairy- and Berry-based Snacks on Nutritional and Functional Status and Quality of Life in Older People

Malnutrition or its risk is common among older people, especially among those receiving home care services. It impairs the quality of life of the older people and results in significant costs to society. To maintain adequate nutrition, increased meal frequency is important. In addition to main meals, regular consumption of tasty, convenient, nutrient- and energy-dense snacks is recommended. The purpose of this study is to investigate the effects of dairy- and berry-based snack consumption on nutritional and functional status and quality of life among vulnerable older people at home care.

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Key information

Conditions

Nutrition Disorders in Old Age

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland

Kuopio, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Home care clients of the City of Kuopio

Exclusion criteria

  • Advanced dementia

Treatment and study plan

Dairy- and berry-based snacks

Dietary Supplement

High-protein dairy-based products and energy-enriched berry products for three months

Primary outcomes

  1. Nutritional status

    Time frame: Baseline and 3 months

    Nutritional status is assessed by the Mini Nutritional Assessment (MNA) test which is a validated and standardized tool for detecting malnutrition and its risk in older people. Scores 24.0 - 30.0 indicate normal nutritional status, scores 17.0 - 23.5 risk of malnutrition and scores < 17.0 malnutrition. Change in the MNA score is determined.

  2. Albumin

    Time frame: Baseline and 3 months

    Change in plasma albumin concentration

  3. Prealbumin

    Time frame: Baseline and 3 months

    Change in plasma prealbumin concentration

  4. Hand grip strength

    Time frame: Baseline and 3 months

    Change in grip strength of both hands

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: Baseline and 3 months

    Change in BMI

  2. Mid-arm muscular area (MMA)

    Time frame: Baseline and 3 months

    Change in MMA

  3. Hemoglobin

    Time frame: Baseline and 3 months

    Change in blood hemoglobin concentration

  4. C-reactive protein (CRP)

    Time frame: Baseline and 3 months

    Change in plasma high-sensitivity CRP concentration

  5. Activity and sleep assessed by ActiGraph monitoring

    Time frame: Baseline and 3 months

    Changes in several parameters describing physical activity and quality of sleep

  6. Health-related quality of life

    Time frame: Baseline and 3 months

    Health-related quality of life is assessed by the 15D instrument. It is a generic, standardized instrument consisting of 15 dimensions: moving, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental functioning, discomfort/symptoms, depression, distress, vitality, and sexual activity. Each dimension is divided into five levels by which more or less an attribute is distinguished. In this study 15D is used as single index score measure. The single index score (15D score) is calculated from the health state descriptive system through the use of an additive three-stage valuation model based on the multiattribute utility theory. The preference weights for the 15 dimensions, and their levels have been elicited from representative population samples. The 15D score is on a 0-1 scale, where 1 stands for "full health" and 0 being dead. Change in the 15D score is determined, and a change of ±.03 is clinically important.

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Registry information

Official study title

Tailored Food Solutions for Improving Nutrition and Well-being in Older People. Effects on Nutritional and Functional Status and Quality of Life in Older People at Home Care

Acronym: MAVIRE1

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2017
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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